FDA.reportPublic FDA data

Coronary Bypass Marker

Primary DI
B776106961
Brand
Coronary Bypass Marker
Company
FIRST CALL, INC.
Model
Rev1
Catalog number
10-696
Device description
Suturing Washer
Published
2019-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MABMarker, Cardiopulmonary Bypass (Vein Marker)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MABMarker, Cardiopulmonary Bypass (Vein Marker)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052642000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052642000SUTURING WASHERFirst Call, Inc.2006-01-17MAB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B776106961PrimaryHIBCC0
B7761069619Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic coronary bypass marker, non-sterileA non-sterile device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a metal (e.g., stainless steel) ring which is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy]. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
015526185
Device count
3
Serial number
true
Sterilization required before use
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026704523054PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523061PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523078PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
04026704523085PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523058PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523065PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523072PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
24026704523089PILLINGTELEFLEX INCORPORATEDMAB2016-09-16
00846159001037SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001034SCANLAN® A/C Locator® graft markerSCANLAN INTERNATIONAL INCMAB2015-08-28
10846159001041Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025644Scanlan® RADIOMARK® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27
00846159025651Scanlan® A/C LOCATOR® graft markersSCANLAN INTERNATIONAL INCMAB2015-08-27